While the value of real-world data (RWD) is increasingly being recognized, consensus on its definition is lacking. The objective of this article was to systematically review publically available definitions for RWD to clarify the similarities and differences between them.

Using a literature review and stakeholder interviews, the authors found that a spectrum of data exists in how RWD is defined in the field. On one end, the highly controlled randomized controlled trial (RCT) is the least representative of RWD. On the other end, the non-experimental setting of electronic health records (EHRs), where no intervention is implemented by the investigator and no additional data are collected (other than data from routine clinical practice), is considered the most representative of RWD. More importantly, what stakeholders perceive as RWD within this broad spectrum of data is subject to the definition they apply to the concept. This has direct implications on which data sources do, or do not, qualify as being representative of the real-world.

The study identified 38 definitions of RWD, which were coded into 4 categories:

Category 1 defined RWD as any data collected in a non-RCT setting (53%)

Category 2 defined RWD as data collected in a non-interventional/non-controlled setting (i.e., data collected without interference with one or all of the following: treatment assignment, patient monitoring/ follow-up and selection of study population) (24%)

Category 3 defined RWD as data collected in a non-experimental setting (i.e., the investigator has no control over any of the conditions and no de novo data collection occurs based on pre-established study protocols) (13%)

Category 4 included definitions that did not fit in the previous categories (11%)

“This paper highlights the similarities and differences in the wider communities’ understanding of the concept of RWD, the types of data sources they consider to be RWD, and the study designs they consider to generate RWD,” said lead author Amr Makady, MSc, National Healthcare Institute (ZIN), The Netherlands. “Despite the fact that most documents and stakeholders defined RWD as data ‘not collected in the context of a RCT,’ this perception was not unanimous. Other definitions differed and often contradicted one another.” Makady also noted that, “a considerable number of stakeholders do not have an official, institutional definition for RWD nor have adopted any of those developed by ISPOR, RAND, ABPI, or IMI-GetReal.”

The authors support movement toward the development of a common understanding of what RWD precisely means, the types of information it may inform, the types of data sources that qualify as RWD, and study designs that generate RWD. In doing so, stakeholders can ensure that future work involving the collection and use of RWD for drug development, drug regulation, and health technology assessment delivers the greatest value to the widest audience.

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